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A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Trial Information

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

This amendment is to update the definitions of adverse event relationship to study vaccine.

Inclusion Criteria

- Participant is not sexually active and does not plan on becoming sexually active
during the study

- Participant has received a documented full primary immunization series against
diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus),
but not in the last 5 years. There must be a 5-year interval from a prior
vaccination containing any one of these vaccine antigens.

Exclusion Criteria:

- Participant has a known allergy to any vaccine component of V503 or REPEVAX™

- Participant has had a severe reaction affecting the brain (e.g., evolving
encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine

- Participant has had a progressive severe illness affecting the brain after a previous
dose of tetanus, diphtheria, poliovirus or a component pertussis combination
(acellular and whole cell) vaccine

- Participant ever had Guillain-Barré syndrome or brachial neuritis following a
previous dose of a tetanus-containing vaccine

- Participant has a condition that is a contraindication to vaccination as indicated in
the most up to date package inserts of REPEVAX™

- Participant has a history of severe allergic reaction that required medical
intervention

- Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy
and/or has any coagulation disorder that would contraindicate intramuscular
injections

Study ID:

NCT ID:

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Completion Date:

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